NECESSITY,
FUNCTION, AND CONFORMITY: KRS Chapter 333 directs that all medical laboratories
in Kentucky shall establish a quality control program acceptable to the Cabinet
for Human Resources, and authorizes the cabinet to adopt reasonable rules and
regulations to effectuate the purposes of KRS Chapter 333, including standards
of performance in the examination of specimens. This administrative regulation
is to ensure accuracy of test results by control of medical laboratory
equipment, methods, and samples.

Section 1.
Quality Control; General Practices. Each medical laboratory shall establish a
quality control program covering all types of analyses performed by the
laboratory for verification and assessment of accuracy, measurement of
precision, and detection of error. The program shall provide for the following:

(1) Preventive
maintenance, periodic inspection, and testing for proper operation of equipment
and instruments as may be appropriate; validation of methods; evaluation of
reagents; surveillance of results; and remedial action to be taken in response
to detected defects.

(2) Adequacy
of facilities, equipment, instruments, and methods for performance of the
procedures or categories of procedures for which a license application is filed
or granted; proper lighting for accuracy and precision; monitoring of
temperature-controlled spaces and equipment, including water baths, incubators,
sterilizers, and refrigerators, to ensure proper performance; evaluation of
analytical measuring devices, such as photometers and radioactivity counting
equipment, with respect to all critical operating characteristics.

(3) Labeling
of all reagents and solutions to indicate identity and, if significant, titer,
strength or concentration, recommended storage requirements, preparation or
expiration date, and other pertinent information; assure that material of
substandard reactivity or deteriorated materials are not used.

(4) The
availability at all times, in the immediate bench area in which staff is
engaged in examining specimens and performing related procedure within a
category (e.g., clinical chemistry, hematology, and pathology) of current
laboratory manuals or other complete written descriptions and instructions
relating to:

(a) The
analytical methods to be used by the staff, properly designated and dated to
reflect the most recent supervisory reviews;

(b) Reagents;

(c) Control
and calibration procedures; and

(d) Pertinent
literature references. Textbooks may be used as supplements to the written
descriptions but may not be used in lieu thereof.

(5) Written
approval by the director or supervisor of all changes in laboratory procedures.

(6)
Maintenance and availability to laboratory personnel and to the cabinet of
records, reflecting dates and, if appropriate, the nature of inspection,
validation, remedial action, monitoring, evaluation, and changes and dates of
changes in laboratory procedures.

(7) Solicitation
designed to provide for the collection, preservation, and transportation of
specimens sufficiently stable to provide accurate and precise test results
suitable for clinical interpretation.

Section 2.
Quality Control for Particular Specialties and Subspecialties. In addition to
the quality control provisions required under Section 1 of this administrative
regulation, each medical laboratory shall provide for additional controls which
pertain to the particular specialties and subspecialties in which the
laboratory is involved. In establishing the controls, the following rules shall
apply:

(1) If the
laboratory performs tests in the specialty of microbiology, chemical and
biological solutions, reagents, and antisera shall be tested and inspected each
day of use for reactivity and deterioration.

(a) If the
laboratory performs tests in the subspecialties of bacteriology and mycology,
staining materials shall be tested for intended reactivity by application to
smears of microorganisms with predictable staining characteristics; and each
batch of medium shall be tested before, or concurrently with, use with selected
organisms to confirm required growth, characteristics, selectivity, enrichment,
and biochemical response.

(b) If the
laboratory performs tests in the subspecialty of parasitology, a reference
collection of slides, photographs, or gross specimens of identified parasites
shall be available and used in the laboratory for appropriate comparison with
diagnostic specimens; and a calibrated ocular micrometer shall be used for
determining the size of ova and parasites, if size is a critical factor.

(c) If the
laboratory performs tests in the subspecialty of virology, systems for the
isolation of viruses and reagents for the identification of viruses shall be
available to cover the entire range of viruses which are etiologically related
to clinical diseases for which services are offered; records shall be
maintained which reflect the systems used and the reactions observed; in tests
for the identification of viruses, controls shall be employed which identify
erroneous results; and if sero-diagnostic tests for virus diseases are
performed, requirements for quality control as specified for serology shall
apply.

(2) If the
laboratory performs tests in the specialty of serology, the following controls
shall be established:

(a) Serologic
tests on unknown specimens shall be run concurrently with a positive control
serum of known titer or controls of graded reactivity plus a negative control
in order to detect variations in reactivity levels.

(c) Test
results shall not be reported unless the predetermined reactivity pattern of
the controls is obtained.

(d) Equipment,
glassware, reagents, controls, and techniques for tests for syphilis shall
conform to those recommended in the "Manual of Tests for Syphilis",
American Public Health Association, 1990, incorporated by reference, or to any
subsequent revisions. A copy of the "Manual of Tests for Syphilis"
may be inspected or obtained at the Office of the Commissioner for Health
Services, 275 East Main Street, Frankfort, Kentucky 40621, Monday through
Friday, 8 a.m. until 4:30 p.m.

(3) If the
laboratory performs tests in the specialty of clinical chemistry:

(a) Each
instrument or other device shall be recalibrated or rechecked at least once on
each day of use. Records which document the routine precision of each method,
automated or manual, and its recalibration schedule shall be maintained and
available to laboratory personnel and the cabinet; at least one (1) standard
and one (1) reference sample (control) shall be included each day of testing
unknown specimens; and control limits for standards and reference samples shall
be recorded and displayed and shall include the course of action to be
instituted if the results are outside the acceptable limits.

(b) Screening
or qualitative chemical urinalysis shall be checked daily by use of suitable
reference samples.

(4) If the
laboratory performs tests in the specialty of immunohematology:

(a) ABO
grouping shall be performed by testing unknown red cells with anti-A and anti-B
grouping serums licensed under Part 73, Title 42, Code of Federal Regulations,
or possessing equivalent potency, using the technique for which the serum is
specifically designed to be effective; for confirmation of ABO grouping the
unknown serum shall be tested with known A1 and B red cells.

(b) The Rho(D)
type shall be determined by testing unknown red cells with anti-Rho (anti-D)
typing serum licensed under 42 CFR Part 73, or possessing equivalent potency
using the technique for which the serum is specifically designed to be
effective; anti-Rho' (CD), anti-Rho" (DE) and anti-Rhorh'rh" (CDE)
serums licensed pursuant to 42 CFR Part 73, or possessing an equivalent
potency, may be used for typing donor blood; all Rho negative donor and patient
cells shall be tested for the Rho variant (Du); a control system of patient's
cells suspended in his own serum or in albumin shall be employed if the test is
performed in a protein medium.

(c) The
potency and reliability of reagents (antisera, known test cells, and
antiglobulin - Coombs serum) used for ABO grouping, Rh typing, antibody
detection, and compatibility determinations shall be tested for reactivity on
each day of use and if a new lot of reagents is used.

(5) If the
laboratory performs tests in the specialty of hematology, instruments and other
devices used in hematological examination of specimens shall be recalibrated,
retested, or reinspected, as may be appropriate, each day of use; each
procedure shall be rechecked each day of use with two (2) levels of controls;
tests such as the one (1) stage prothrombin time test shall be run in duplicate
unless the laboratory can demonstrate that low frequency of random error or
high precision makes the testing unnecessary; standard deviation, coefficient
of variation, or other statistical estimates of precision shall be determined
by random replicate testing of specimens; and the accuracy and precision of
blood cell counts, hematocrit, and hemoglobin measurements shall be tested each
day of use.

(6) If the
laboratory performs tests in the specialties of exfoliative cytology,
histopathology, or oral pathology, the following controls shall be established:

(a) If the
laboratory performs tests in the specialty of exfoliative cytology, the
laboratory director or supervisor qualified in cytology shall rescreen for proper
staining and correct interpretation at least a ten (10) percent random sample
of gynecological smears which have been interpreted to be in one (1) of the
benign categories by personnel not possessing director or supervisor
qualifications; all gynecological smears interpreted to be in the
"suspicious" or positive categories by screeners shall be confirmed
by the laboratory director or qualified supervisor and the report shall be
signed by a physician qualified in pathology or cytology; all nongynecological
cytological preparations, positive or negative, shall be reviewed by a director
or supervisor qualified in cytology; nonmanual methods shall provide quality
control similar to that in other nonmanual laboratory procedures; and all
smears shall be retained for not less than five (5) years from date of examination.

(b) If the
laboratory performs tests in the specialties of histopathology and oral
pathology, all special stains shall be controlled for intended reactivity by
use of positive slides; stained slides shall be retained for not less than two
(2) years from date of examination, and blocks shall be retained for not less
than one (1) year from the date of examination; and remnants of tissue
specimens shall be retained in a fixative solution until those portions
submitted for microscopy have been examined and a diagnosis made by a
pathologist.

(7) If the
laboratory performs tests in the specialty of radiobioassay, the counting
equipment shall be checked for stability at least once each day of use, with
radioactive standards or reference sources; reference samples with known
activity and within expected levels of normal samples shall be processed in
replicate quarterly; for each method, records which document the routine
precision and the recalibration schedule shall be maintained and be available
to the staff and the cabinet. (3 Ky.R. 204; eff. 5-4-77; Am. 20 Ky.R. 2189;
eff. 3-14-94.)